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Study of Gemcitabine+Platinum Salt+Bevacizumab Combination for Metastatic Collecting Duct Carcinoma (GETUG-AFU 24)

NCT02363751 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2021-03-09

No results posted yet for this study

Summary

Open-label, non-randomized, multicenter, phase II, single arm non comparative trial evaluating toxicity and efficacy of gemcitabine plus platinum salt in combination with bevacizumab in first-line setting in metastatic collecting duct carcinoma.

Conditions

  • Collecting Duct Carcinoma (Kidney)

Interventions

DRUG

Bevacizumab

Patients will be treated for a maximum of 6 (21days) chemotherapy cycles (Gemcitabine+platinum salt+bevacizumab). In case of disease control (complete, partial or stable disease) treatment with bevacizumab 15 mg/Kg monotherapy every 21 days will be continued until disease progression or until the end of the 24 months of follow-up.

Sponsors & Collaborators

  • UNICANCER

    lead OTHER

Principal Investigators

  • Constance THIBAULT, Dr · Hôpital Européen Georges-Pompidou

  • Marc-Olivier TIMSIT, Dr · Hôpital Européen Georges-Pompidou

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2020-03-31
Completion
2020-08-31

Countries

  • France

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02363751 on ClinicalTrials.gov